PUERTA: A novel treatment for patients in acute respiratory distress

This study is for patients who have been hospitalised with symptoms of Acute Respiratory Distress Syndrome (ARDS). ARDS is a life-threatening condition, characterised by severe breathing difficulty, which may result from COVID infection and other causes. Patients suffering from ARDS normally require mechanical ventilation and are at risk of suffering damage to the lungs and other organs.

This trial is testing a new drug, which works by a novel mechanism of action to reduce inflammation and prevent lung injury in ARDS.

Category
Surgical
Trial status
Recruiting
Trial phase
Phase 2 Drug Trial
Early stage studies investigating efficacy and safety compared to standard therapies, as well as final dose determination in moderate sized patient cohorts.
Registry listing
NCT05938036
ERM Project ID
101064

Trial contact details

Contact person
Katherine Jongebloed, Clinical Trial Coordinator
Email
Katherine.Jongebloed@mater.org.au
Phone
07 3163 1640

What you need to know

Who can take part?

Patients who are eligible for this study may be unable to provide their own consent, due to their medical condition. In such cases, consent to participate will be obtained via a legally authorized representative (termed a Person Responsible in Queensland), such as a parent, guardian or next of kin.

To be eligible to participate in the study, a patient must meet the following criteria:
•   People aged 18 years or older
•   Females must not be pregnant
•   Hospitalised, or planned to be hospitalized, with ARDS
•   Certain health and medical conditions and prior medications may prevent participation, as confirmed by the study doctor

What is involved for you?

Study participants will be administered study drug or placebo by intravenous infusion while they are hospitalized for ARDS. In addition, they will undertake the following procedures, tests and assessments:

•   Physical exam and medical history
•   Blood tests
•   Urine tests
•   Pregnancy tests in women who can have children
•   Electrocardiogram
•   Chest X-Ray
•   Health questionnaires administered after discharge from hospital

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